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    Summary
    EudraCT Number:2016-002855-48
    Sponsor's Protocol Code Number:BAY1002670/15789
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-05-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-002855-48
    A.3Full title of the trial
    A randomized, parallel-group, double-blind, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids
    A.3.2Name or abbreviated title of the trial where available
    ASTEROID 5
    A.4.1Sponsor's protocol code numberBAY1002670/15789
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address"EU CTR"
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 1002670 coated tablet 2 mg 245
    D.3.2Product code BAY 1002670
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvilaprisan
    D.3.9.1CAS number 1262108-14-4
    D.3.9.2Current sponsor codeBAY 1002670
    D.3.9.3Other descriptive nameBAY 1002670
    D.3.9.4EV Substance CodeSUB31208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Leiomyoma
    E.1.1.1Medical condition in easily understood language
    Uterine fibroids, heavy menstrual bleeding
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10046784
    E.1.2Term Uterine fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10016628
    E.1.2Term Fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10022794
    E.1.2Term Intramural leiomyoma of uterus
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent
    2. Women, 18 years or older at the time of Visit 1
    3. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter 30 mm
    4. The largest diameter of any uterine fibroid < 120 mm
    5. Heavy menstrual bleeding (HMB) > 80.00 mL documented by menstrual pictogram (MP) in a bleeding period during the screening period
    Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, eg, with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures.
    Women suffering from perceived HMB despite medical treatment, eg, with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior
    medication (see exclusion criterion 7) are followed.
    Heavy menstrual bleeding (HMB) > 80.00 mL should be documented within 10 consecutive days. As a guidance, the duration of a bleeding episode should not exceed 12 days.
    6. Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
    7. Normal or clinically insignificant cervical smear not requiring further follow-up. The cervical smear may be waived if a normal result has been documented in the subject’s
    medical records within the previous 6 months.
    Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with
    ASCUS can be included if they are negative for high-risk HPV strains.
    8. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or
    other significant endometrial pathology. If the sample is inadequate, the biopsy can be repeated once within the screening period and must be repeated within 6 weeks from the
    first biopsy in order for the subject to continue. No further repeated biopsies for inadequate samples are permitted.
    9. Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study. (Short-acting hormonal contraception [oral, vaginal, or transdermal] are allowed up until the start of the menstrual cycle that follows Visit 1.) This is not required if contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject (including Essure®) or vasectomy of the partner(s).
    E.4Principal exclusion criteria
    1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
    2. Hypersensitivity to any ingredient of the study drugs
    3. Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with haemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation).
    4. Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including, but not limited to:
    • Impaired function of the kidneys (laboratory values outside of inclusion range)
    • Abnormal liver parameters (presence of at least one of the following criteria please see also Section 9.6.3.1 Laboratory evaluations):
    - 2 x upper limit of normal (ULN) for glutamic oxaloacetic transaminase (GOT) / aspartate aminotransferase (AST)
    - 2 x ULN for glutamic pyruvic transaminase (GPT) / alanine aminotransferase (ALT)
    - 2 x ULN for alkaline phosphatase (AP)
    - Total bilirubin outside the upper limit of normal
    - International normalized ratio (INR) outside the upper limit of the normal range
    • Diagnosis of hepatitis B infection, i.e., Hbs-antigen positive at Visit 1
    • Diagnosis of hepatitis C infection, i.e., hepatitis C-antibodies and HCVRNA positive at Visit 1
    • Chronic bowel diseases, eg, M. Crohn and Colitis ulcerosa
    • Intake of strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors within the last 2 weeks before the randomisation visit and during the treatment period, including: antivirals (eg, viekira pak, telaprevir, boceprevir), protease inhibitors (eg, ritonavir, lopinavir, indinavir, nelfinavir, saquinavir), antifungals (eg, itraconazole, voriconazole, posaconazole), antibiotics (eg, clarithromycin, telithromycin), grapefruit and any grapefruit containing food products (eg, grapefruit juice). Ketoconazole and other triazole antifungal drugs are allowed for topical/local use (including vaginal application).
    • Intake of strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarbital, St John´s wort [hypericum]) within the last 2 weeks before
    the randomization visit and during the treatment period.
    5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results, including
    • Known severe coagulation disorder
    • Known anemia for reason other than HMB
    • Known hemoglobinopathy
    • History of or current uterine, cervical, ovarian or breast cancer (except cervical cancer after curative treatment)
    • One or more ovarian cysts >30 mm in diameter as measured by ultrasound (except endometrioma)
    • Any ovarian tumors or pelvic masses of unclear etiology requiring further diagnostic procedures
    • Known or suspected uterine polyp >15 mm
    6. Abuse of alcohol, drugs, or medicines (eg, laxatives)
    7. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results including
    • Short-acting hormonal contraception (oral, vaginal, or transdermal), if not stopped at the start of the menstrual cycle that follows Visit 1.
    • Long-acting hormonal contraception (injectable), if last application was performed less than 1 application interval before the start of the menstrual cycle that follows
    Visit 1.
    • Contraceptive devices with or without hormone release (implant, intra-uterine device), if not removed at Visit 1 (not applicable in cases of
    bilateral fallopian tube blockage of the subject [including Essure®]).
    • Other hormonal treatments for HMB or fibroids, if not stopped before the start of the menstrual cycle that follows Visit 1 (eg, androgens, estrogen receptor antagonists, selective estrogen receptor modulators) For progesterone receptor modulators see next bullet points
    • Previous use of ulipristal acetate without satisfying treatment response
    • Previous use of ulipristal acetate, if there were not at least two menstruations after the last intake before Visit 1
    • Gonadotropin-releasing hormone (GnRH) agonist, if not stopped at least one application interval before Visit 1
    • Tranexamic acid or traditional Chinese medicines for uterine fibroids or HMB, or other treatments for HMB, if not stopped at Visit 1
    • Anticoagulants, if not stopped at Visit 1
    8. Undiagnosed abnormal genital bleeding
    9. Simultaneous participation in another clinical study with investigational medicinal product(s). Participation in another clinical trial prior to study entry that might have an
    impact on the study objectives.
    10. Close affiliation with the investigational site , dependent person (eg, employee or student of investigational site, or sponsor’s staff)
    11. Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site, eDiary compliance
    12. Previous enrollment to the study
    E.5 End points
    E.5.1Primary end point(s)
    Amenorrhea (yes/no), Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.
    E.5.2Secondary end point(s)
    1) Total volume of menstrual blood loss (assessed by MP).
    2) Number of bleeding days
    3) Amenorrhea (yes/no)
    4) Absence of bleeding (spotting allowed)
    5) Time to onset of controlled bleeding
    6) HMB responder rate
    7) Percent change in volume of largest fibroid compared to baseline (measured by MRI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Menstrual blood loss: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
    2) Number of bleeding days: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
    3) Amenorrhea (yes/no), defined as MBL < 2 mL during last 28 days of each TP
    4) Absence of bleeding during the last 28 days of the treatment
    5) Time to onset of controlled bleeding: the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is less than 80mL.
    6) HMB responder rate (Percentage of subjects with blood loss < 80mL per 28 days and 50% reduction compared to baseline
    7) Percent change in volume of largest fibroid compared to baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    3 treatment arms with vilaprisan: A1 - 3/1 regimen; A2 - 6/2 regimen; A3 - 3/2 regimen.
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA219
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Taiwan
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 528
    F.4.2.2In the whole clinical trial 1200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All pregnancies occurring during the treatment and follow-up periods will be followed for the outcome for both the mother and fetus/child (in a case of life birth) until first birthday of the child.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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